AstraZeneca's Imfinzi Plus Chemotherapy Receives US FDA Nod

AstraZeneca's Imfinzi (durvalumab) has been approved as a treatment for adult patients with mismatch repair deficient (dMMR) primary, advanced, or recurrent endometrial cancer, in the United States. This can be followed by Imfinzi monotherapy.

The results of a predetermined exploratory subgroup analysis based on MMR status in the DUO-E phase III trial were the foundation for the FDA's approval. Results from DUO-E were published in the Journal of Clinical Oncology.

Compared to chemotherapy alone, the clinical trial found that patients with dMMR endometrial cancer who received Imfinzi plus carboplatin and paclitaxel followed by Imfinzi monotherapy (the Imfinzi arm) had a 58% lower risk of disease progression or death (hazard ratio 0.42; 95% confidence interval 0.22-0.80).

More than 66,000 women will be diagnosed with common cancer in the United States in 2022, making it the fourth most common type of cancer among women. There is a significant need for new treatment options for people with advanced disease, where the survival rate falls to less than 20%, despite the fact that patients who are diagnosed at an early stage of the disease have a five-year survival rate of approximately 80-90%.

Shannon N. Westin, Professor of Gynaecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, and principal investigator of the trial, said, “With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care. This approval underlines clear evidence that durvalumab plus chemotherapy followed by durvalumab monotherapy delivers important clinical benefits for patients with mismatch repair deficient endometrial cancer.”